Open wedge osteotomy system and surgical method

ABSTRACT

An osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising: a first component for disposition in a posterior portion of the open wedge osteotomy; a second component for disposition in an anterior portion of the open wedge osteotomy; and a connection device for selectively connecting the first component and the second component to one another.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application claims benefit of:

-   -   (1) pending prior U.S. Provisional Patent Application Ser. No.        60/569,545, filed May 7, 2004 by Vincent P. Novak for OPEN WEDGE        OSTEOTOMY SYSTEM AND SURGICAL TECHNIQUE (Attorney's Docket No.        NOVAK-1 PROV);    -   (2) pending prior U.S. Provisional Patent Application Ser. No.        60/603,899, filed Aug. 24, 2004 by Vincent P. Novak for OPEN        WEDGE OSTEOTOMY SYSTEM AND SURGICAL TECHNIQUE (Attorney's Docket        No. NOVAK-2 PROV); and    -   (3) pending prior U.S. Provisional Patent Application Ser. No.        60/626,305, filed Nov. 9, 2004 by Vincent P. Novak for OPEN        WEDGE OSTEOTOMY SYSTEM AND SURGICAL TECHNIQUE (Attorney's Docket        No. NOVAK-3 PROV).

The three above-identified patent applications are hereby incorporatedherein by reference.

FIELD OF THE INVENTION

This invention is related to surgical apparatus and methods in general,and more particularly to apparatus and methods for open wedge osteotomysurgery.

BACKGROUND OF THE INVENTION

Osteotomies about the knee have been an important component of thesurgical treatment in the management of knee osteoarthritis. Theultimate goal of knee osteotomies has been to relieve pain symptoms,slow disease progression and postpone total knee arthroplasty in youngerpatients by transferring weight bearing load to the relativelyunaffected portions of the knee.

The most commonly performed knee osteotomy has been the proximal tibialosteotomy or “high tibial” osteotomy. The first reported tibialosteotomy was in 1958. Knee osteotomy principles and techniquescontinued to evolve through the 1960s and 1970s. Today, however, otherthan at a minority of leading orthopedic centers, proximal tibialosteotomies are generally regarded critically by the general populace oforthopedic surgeons. The overall community holds the opinion that, firstand foremost, the surgical technique of osteotomy is challenging andcumbersome, requiring much practice in the “art” in order to effectivelyperform and reproduce the osteotomy procedure.

More particularly, current techniques generally require the passage ofhand-directed guidewires and hand-guided bone resecting tools whilerequiring continual use of fluoroscopy throughout the procedure. In sucha procedure, the failure to properly execute the required precision canlead to a lack of, or postoperative loss of, correction andcomplications such as delayed union or nonunion, unintended changes tothe slope of the tibial plateau, intraarticular fractures, andneurovascular problems. All of these issues pose a direct risk to asuccessful surgical outcome. In addition, the postoperativerehabilitation period using current techniques may require aconservatively long duration so as to protect the osteotomy frompotential nonunion during the long healing period. Also, currentlypracticed procedures often require a second surgery to remove fixationhardware.

The reported long-term surgical outcomes of high tibial osteotomyprocedures vary considerably. Published research of these proceduresdemonstrates that the relief of pain and restoration of function isgenerally achieved in approximately 80% to 90% of patients at fiveyears, and 50% to 65% of patients at ten years.

The methods and principles of surgically performing an osteotomy haveslowly developed over time. The two common osteotomy methods are: (i)the lateral closing-wedge method; and (ii) the medial opening wedgemethod (with either an internal fixation device or an external fixationdevice). Within these two general categories of surgical methods, thereare varying nuances to the surgical techniques purported by individualorthopedic surgeons. For example, in discussions with individualsurgeons, it is common to hear “this is how I do it” inasmuch as no“gold standard” surgical technique has emerged to date.

The lateral closing wedge method has been the traditional method forosteotomy surgery. This is the most common osteotomy for medialcompartment osteoarthritis. Correction of alignment is typicallyachieved by first removing a laterally-based, angled wedge of bone, andthen closing the resultant opening.

The medial opening wedge method with internal fixation has been gainingin popularity in recent years. Correction of alignment is typicallyachieved by first making a single transverse bone cut into the medialsagittal plane of the knee, and then manually opening the cut underfluoroscopy with a series of osteotomes, or pre-sized wedge osteotomes.This technique generally provides the surgeon with the intraoperativeability to more easily achieve the required correction angle. The wedgeopening is then fixated at a given height with a small fixation plateand bone screws that support the opening of the wedge osteotomy. Theopened bony void is then filled with bone graft material.

The medial opening wedge method with an external fixation device is mostoften used when a large correction is needed in order to achieve properalignment. Correction of alignment is achieved by first making a singlebone cut into the medial sagittal plane of the knee. Next, an externalfixation device is applied and then regularly adjusted, in smallincrements, usually on a daily basis, so as to slowly open the wedge toa desired correction angle. The progress of this surgical technique isusually confirmed with weekly radiographs.

The opening wedge technique has been advocated as a faster, simplersurgical procedure that can be more easily learned while providing abetter method for achieving the desired corrective angle with minimalrisks to surrounding neurovascular structures. However, the variousopening wedge surgical techniques, as currently practiced, allow a widewindow for the introduction of surgical error.

All of these opening wedge osteotomy techniques, as currently practiced,require the hand-guided placement of guide pins to define theanterior-to-posterior tibial slope, sometimes referred to as the APtibial slope, and require the use of hand-held and hand-guidedosteotomes, which are all used under fluoroscopy. The use of frequentfluoroscopic pictures is critical to determine the work performed tothat point in the procedure and the required adjustments still to bemade in the remainder of the procedure. Errors by the surgeon indefining the AP tibial slope can result in an inappropriately-placedosteotomy with unintended changes to the tibial slope, which in turn mayaffect knee stability. Errors in the use of hand-driven osteotomes orhand-guided saw blades in creating the bone cut can lead to tibial slopechanges, migration of the osteotomy into the joint, and/or injury toneurovasculature and soft tissue structures.

Recent evolutionary developments in osteotomies have focused on twogeneral components. One of these includes improved wedge-shapedosteotomes which are used to form or open the bony wedge osteotomy. Theother includes low profile internal fixation plates used during thenonweight-bearing rehabilitation phase to rigidly maintain the wedgeopening, and used during the weight-bearing rehabilitation phase to addsupport to the entire osteotomy site. While significant, these advancesdo not address important issues including, but not limited to, thereduction of the surgical learning curve to make the procedures morereproducible, the improvement of the surgical precision of osteotomyprocedures, the reduction in the use of fluoroscopy, and the fact thatinternal fixation devices used in an open wedge osteotomy effectivelystress-shield the osteotomy or fracture site. Such stress-shielding isoften a factor in complications involving nonunion and loss ofcorrection.

Today, the orthopedic surgeon's requirements are demanding prior to theadoption of a new surgical procedure. The actual demands include apredictive knee osteotomy procedure with accuracy in determining thecorrection angle before surgery, and precision in carrying out thesurgical technique with reproducible results. The ultimate surgicaloutcome depends upon the ability of the surgeon to precisely execute thecorrective angle and to ensure that the correction remains long lasting.

EXAMPLE OF DEFICIENCIES OF THE PRIOR ART

In current surgical practice, if the surgeon desires to institute adesired change in the AP slope (either a change planned frompre-operative x-rays or a change required from intra-operative bone cutsduring a routine knee osteotomy), the surgeon is faced with variousoptions to help re-adjust the slope of the bone.

First, the surgeon can place additional bone graft material or solidpieces of bone graft (i.e., allograft bone or synthetic bone) into theosteotomy void, at a specific location within the void, to helpre-adjust the AP slope. However, this practice of “shimming” isfrequently difficult to estimate and calculate during surgery.

Second, and referring to FIG. 1, the surgeon can use a fixation plate 5that provides a specific AP slope change to tibia 10. The difficultywith this approach is the fact that fixation plate 5 only directlysupports a portion of the wedge void 15. A potential complication existswherein even small weight-bearing forces may act upon the slope of thebone and affect the planned slope adjustment in the least supportedareas.

Third, the surgeon may both (i) place solid pieces of bone graft (i.e.,allograft bone or synthetic bone) into the osteotomy void, at a specificlocation within the void, to help re-adjust the AP slope and, inaddition, (ii) utilize a fixation plate 5. Again, this combined approachsuffers from the aforementioned shimming and fixation plate problems.

There are also other issues with the three above-identified options.First, although the exact measurement of an AP slope change may bedetermined pre-operatively, the execution of a planned change isgenerally still carried out with intra-operative adjustments due tooffset cutting planes which require subsequent shims and perhapsre-estimation of the desired sloped fixation plate. Second, even if thesurgeon's intention is not to affect the AP tibial slope, the currentpractice of knee osteotomy almost always ensures that it will beaffected somewhat. With the antero-medial approach, this is due to theoffset cutting plane and the opening of the osteotomy void. The surgeonmust then make intra-operative adjustments with shims and a slopedfixation plate, changes that are visually estimated and notpre-determined from superior pre-operative radiographic means. Third,inaccuracies in carrying out adjustments to the AP slope may result inimmediate poor results following surgery, or the eventual loss ofcorrection adversely affecting long-term outcomes.

OBJECTS OF THE INVENTION

Accordingly, one object of the present invention is to provide animproved open wedge osteotomy system that is instrument-guided andmodular in fashion.

Another object of the present invention is to reduce the overall surgeonlearning curve in performing an open wedge osteotomy procedure.

Another object of the present invention is to provide an improved openwedge osteotomy system that allows a more surgically reproducibleprocedure and reduces surgical error.

A still further object of the present invention is to provide animproved open wedge osteotomy system that allows the procedure to beperformed more quickly.

Another object of the present invention is to provide an improved openwedge osteotomy system that reduces or eliminates the need forfluoroscopy during the procedure.

A further object of the present invention is to provide an improved openwedge osteotomy system that defines the anterior-to-posterior tibialslope from visual inspection, and enables marking of the naturalanterior-to-posterior joint line without the use of radiographicimaging.

A still further object of the present invention is to provide animproved open wedge osteotomy system that accurately executespre-operative measurements.

A further object of the present invention is to provide an improved openwedge osteotomy system in which the natural joint line is marked by thepositioning and fixation of a guide device on which a system of bonecutting guides is attached, whereby to reliably provide a transverse cutthrough the bone according to the physician's pre-operativecalculations.

A still further object of the present invention is to provide animproved open wedge osteotomy system that accurately defines the cuttingplane in relation to the AP tibial slope.

A still further object of the present invention is to provide animproved open wedge osteotomy system that maintains a consistent angledcutting plane from the posterior aspects of the bone to the anterioraspects of the bone, and that passes through the sagittal plane duringbone resection.

A still further object of the present invention is to provide animproved open wedge osteotomy system that accurately opens the osteotomyvoid to the desired angle while decreasing the risks of changing the APtibial slope and the risk of bone fracture.

Another object of the present invention is to provide an improved openwedge osteotomy system that reduces or eliminates the use of staticinternal fixation plates and screws.

Another object of the present invention is to provide an improved openwedge osteotomy system that better promotes the physiologic growth ofbone across the osteotomy site.

Another object of the present invention is to provide a multi-partimplant system that rims the periphery of the osteotomy void, allowingfor the containment of various bone graft materials while supporting thereoriented bone segments.

A still further object of the present invention is to provide amulti-part implant system for custom assembly in-situ by a surgeon.

A still further object of the present invention is to provide a methodfor creating an osteotomy in which a multi-part implant is introducedinto the osteotomy void part by part, so as to facilitate a minimallyinvasive procedure, and wherein the implant parts are subsequentlyassembled in-situ by the surgeon.

A still further object of the present invention is to provide amulti-part implant system that allows graft materials to be optimallycompacted or inserted within the osteotomy void and contained by themulti-part implant system.

A still further object of the present invention is to provide amulti-part implant system in which implant parts of varying measurementsare assembled together in order to enable accurate adjustments to the APtibial slope.

A still further object of the present invention is to provide amulti-part implant system that accurately maintains and supports thetibial plateau at a desired slope from its anterior aspect to itsposterior aspect.

A still further object of the present invention is to provide amulti-part implant system in which the implant parts support theperiphery of bone and the subsequent passage of screws or fastenerdevices through the implant parts and into surrounding bone secures themulti-part implant in place.

A still further object of the present invention is to provide amulti-part implant system in which channels lead to the surfaceinterface between the implant and the host bone, whereby to facilitatethe directed injection of bone glues, cements, biologic materials orgrafting materials.

A still further object of the present invention is to provide amulti-part implant system in which two implant parts comprise differentbiomaterials, biocomposites or formulations thereof, so as to allow fordifferent rates of selective resorption of the implant parts.

A still further object of the present invention is to provide anosteotomy system in which a positioning guide is positioned on top ofthe skin and percutaneously fixed to the tibia so as to provide aminimally invasive osteotomy.

SUMMARY OF THE INVENTION

With the above and other objects in view, in one form of the invention,there is provided an osteotomy implant for supporting an open wedgeosteotomy, the osteotomy implant comprising:

-   -   a first component for disposition in a posterior portion of the        open wedge osteotomy;    -   a second component for disposition in an anterior portion of the        open wedge osteotomy; and    -   a connection device for selectively connecting the first        component and the second component to one another.

In another form of the invention, there is provided a multi-partosteotomy implant for supporting an open wedge osteotomy, the osteotomyimplant comprising:

-   -   a first component for disposition in a posterior portion of the        open wedge osteotomy;    -   a second component for disposition in an anterior portion of the        open wedge osteotomy;    -   a third component for disposition in a medial portion of the        open wedge osteotomy;    -   a first connection mechanism for selectively connecting the        first component to the third component; and    -   a second connection mechanism for selectively connecting the        second component to the third component.

In another form of the invention, there is provided an osteotomy implantfor supporting an open wedge osteotomy, the osteotomy implantcomprising:

-   -   a leading edge having a first height, a first width, and the        first height configured for placement into a distal portion of        the open wedge osteotomy;    -   a base portion in opposition to the leading edge, the base        portion having a second height, a second width, and the second        height configured to substantially close a proximal end of the        open wedge osteotomy; and    -   two opposing side walls connecting the leading edge to the base        portion, the opposing side walls having a first length equal to        the distance from the leading edge to the base portion, and the        opposing side walls having a tapered height from the first        height of the leading edge to the second height of the base        portion.

In another form of the invention, there is provided an osteotomy implantfor supporting an open wedge osteotomy, the osteotomy implantcomprising:

-   -   a base portion having a first height, a first end and a second        end, a width between the first end and the second end, the first        height configured to substantially close a proximal end of the        open wedge osteotomy;    -   two opposing side walls extending from the first end and the        second end, respectively, the two opposing side walls having a        third end and a fourth end, the third end extending from the        base portion, a second height equal to the first height of the        base portion at the third end, each one of the two opposing side        walls at the fourth end having a third height, the third height        being less than the second height so as to allow placement of        the fourth end of each one of the two opposing side walls into a        distal portion of the open wedge osteotomy.

In another form of the invention, there is provided an osteotomy implantfor supporting an open wedge osteotomy, the osteotomy wedge implantcomprising:

-   -   two opposing side walls having a first end and a second end in        opposition to one another, a pair of frame members extending        between the first end and the second end of each of the two        opposing side walls, an expandable material disposed between the        pair of frame members of each of the two opposing side walls,        the pair of frame members in connection with one another at the        first end thereof, and the pair of frame members selectively        separable from one another to a selected height at the second        end thereof;    -   a base member having a given height and a given width, wherein        the given height is substantially equal to the selected height        of the pair of frame member of each of the two opposing side        walls, and wherein the given width is substantially equal to a        distance between the two opposing side walls when placed in the        open wedge osteotomy; and    -   a set of connectors for connecting the base member to each of        the two opposing side walls.

The above and other features of the invention, including various noveldetails of construction and combinations of parts and method steps, willnow be more particularly described with reference to the accompanyingdrawings and pointed out in the claims. It will be understood that theparticular devices and method steps embodying the invention are shown byway of illustration only and not as limitations of the invention. Theprinciples and features of this invention may be employed in various andnumerous embodiments without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which are tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view of an osteotomy system using a prior art boneplate;

FIGS. 2-5 are schematic views of a novel positioning guide 20 which isillustrative of one component of a preferred embodiment of the novelosteotomy system;

FIGS. 6-12 are schematic views of a novel cutting guide 45 which isillustrative of another component of a preferred embodiment of the novelosteotomy system;

FIGS. 13-16 and 16A, are schematic views of a novel mechanical jack 90which is illustrative of another component of a preferred embodiment ofthe novel osteotomy system;

FIGS. 17-27 are schematic views of a novel multi-part implant 125 whichis illustrative of one component of a preferred embodiment of the novelosteotomy system;

FIGS. 28-31 are schematic views of a medial-to-lateral approach for anosteotomy procedure;

FIGS. 32-34 are schematic views of an antero-medial approach for anosteotomy procedure;

FIGS. 35-37 are schematic views of a method to determine the correctivealignment to be made to a patient's femoral head to tibial-talar jointmechanical axis;

FIGS. 38-47 are schematic views of an alternative mechanical jack 300which is illustrative of an alternative component of a preferredembodiment of the novel osteotomy system;

FIGS. 48-89 are schematic views of alternative novel implants 500 whichare illustrative of alternative embodiments for the novel multi-partimplant shown in FIGS. 17-27;

FIGS. 90-110 are schematic views of a novel resection system 700,comprising a two blade positioning guide and a resection guide, which isillustrative of an alternative embodiment for the novel positioningguide shown in FIGS. 2-5 and for the novel cutting guide system shown inFIGS. 6-12; and

FIGS. 111-130 are schematic views of a novel expandable wedge implant805 which is illustrative of an alternative embodiment for the novelmulti-part implant 125 shown in FIGS. 17-27.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Overview

The present invention comprises surgical apparatus and methods forperforming open wedge osteotomies. In one preferred embodiment of thepresent invention, the system embodies several novel devices and methodsthat provide for precise bone resection, precise control in opening anosteotomy void in the bone, precise achievement of the corrective anglefor the open wedge osteotomy, and precise maintenance of the open wedgeosteotomy that provides for the containment of bone graft or fillermaterials. The present invention provides an instrumentation-guidedsystem with a minimally invasive approach for performing open wedgeosteotomy procedures. In addition, the present invention provides animplant fixation system that promotes new bone growth and a strong bonerepair.

In one preferred form of the invention, the surgical system comprisesfour primary components: (i) a positioning guide 20 (FIG. 2) forestablishing the orientation of the system relative to the patient'stibia; (ii) a cutting guide 45 (FIG. 7) for directing the osteotomy cutthrough the bone; (iii) a mechanical jack 90 (FIG. 15) for opening theosteotomy void in the bone; and (iv) a multi-part implant 125 (FIG. 20)for supporting the open wedge osteotomy during bone healing.

In accordance with the present invention, the surgeon first identifiesthe proper bone cut to be made in the tibia. Once surgeon has identifiedthe proper attributes of the bone cut, the surgeon then uses the methodand apparatus of the present invention to effect the bone resection.

More particularly, the surgeon preferably:

-   -   (i) attaches positioning guide 20 to the proper location on        patient's tibia;    -   (ii) selects the proper cutting guide 45 to be attached to        positioning guide 20, whereby to define the target slope (or        plane) of the cut to be made in the tibia;    -   (iii) selects the proper protector members 70, 75 to be attached        to the cutting guide 45, whereby to protect the soft tissue and        neurovasculature structures surrounding the tibia;    -   (iv) secures the cutting guide 45 to positioning guide 20, and        then secures protector members 70, 75 to the cutting guide 45;    -   (v) selects the proper cutting blade 65 to be used in the        procedure, whereby to define the proper depth of the cut to be        made in the tibia;    -   (vi) passes cutting blade 65 through guide slot 50 formed in        cutting guide 45 and through tibia 10, following the pathway 65A        established by cutting guide 45, until the cut has been made to        the proper depth;    -   (vii) withdraws cutting blade 65;    -   (viii) uses mechanical jack 90 to open the cut in the bone to        the proper angle; and    -   (ix) inserts the multi-part implant 125 into the osteotomy void        110 created in the bone, whereby to hold the resected tibia in        the proper configuration.

Preferably, bone cement or bone paste, etc. is inserted into interior ofthe osteotomy void, within multi-part implant 125, whereby to facilitatestrong bone regrowth and/or bony ingrowth; and preferably bone cement isinjected into the implant/bone interface to help further secure themulti-part implant to the bone.

Significantly, with the present invention, the bone cut is made easilyand reliably using an antero-medial approach, while providing excellentprotection of the soft tissue and neurovasculature structuressurrounding the tibia. Furthermore, osteotomy stabilization is achievedthrough the use of an implant device that provides stability about theosteotomy site while allowing the direct contact of bone graft materialwith native bone within the open wedge osteotomy. Significantly, thepresent invention also allows for the necessary physiologic compressionand stimulation required to promote new tissue and bone growth throughthe bony void. This is in sharp contrast with prior art open wedgeosteotomy systems, which use fixation plates and screws to maintain andsupport the corrective wedge opening; such systems do not allowbeneficial physiologic compressive forces to act on the bone/graftinterfaces. This can lead to nonunion osteotomies and failedcorrections.

Positioning Guide 20

Looking next at FIGS. 2-5, in a preferred embodiment of the presentinvention, there is provided a positioning guide 20 which is configuredto be aligned along the joint line of tibia 10 (FIG. 3) and fixed inplace. In particular, the top of positioning guide 20 is aligned withthe tibial plateau (i.e., the AP tibial slope), as shown in FIG. 4.Positioning guide 20 preferably includes a pair of fixation screwpassageways 25 and a threaded attachment bore 30.

Referring now to FIGS. 3-5, there is shown a pair of fixation screws 35extending through positioning guide 20 and into tibia 10 so as to fixpositioning guide 20 to tibia 10 after the top of positioning guide 20is aligned with the top of tibia 10. An attachment screw 40 (FIGS. 4 and5) is preferably provided for removable attachment of various devices topositioning guide 20. Attachment screw 40 preferably includes a threadedshaft configured for engagement with threaded attachment bore 30.

Cutting Guide 45

Looking next at FIGS. 6-12, there is shown a cutting guide 45 configuredfor attachment to positioning guide 20. Cutting guide 45 is preferablysecured to positioning guide 20 with attachment screw 40. As seen inFIG. 7, a cutting guide slot 50 provides a fixed angle by which acontrolled bone resection can be performed.

More particularly, and referring now to FIGS. 8 and 9, cutting guide 45comprises a throughbore 55 (FIG. 8) which receives the attachment screw40 (FIG. 7) so as to mount cutting guide 45 to positioning guide 20,whereby to position the angled cutting slot 50 relative positioningguide 20 (and hence relative to the AP tibial slope). Preferably,mounting clamps 60 (FIG. 8) are provided at the side portions of cuttingguide 45 for mounting protector members 70, 75 (see below) to cuttingguide 45. A cutting blade 65 (FIG. 9) is selectively inserted throughguide slot 50 so that the cutting blade 65 can cut along pathway 65A ata predetermined angle relative to cutting guide 45 (and hence, relativeto the AP tibial slope).

Referring to FIG. 10-12, cutting guide 45 preferably comprises protectormembers 70, 75 to protect soft tissue and neurovascular structuresduring bone cutting. Protector members 70, 75 are (i) inserted into thepatient through small medial surface incisions; (ii) passed beneath theskin tissue, close to the front and back surfaces of tibia 10; and (iii)secured to cutting guide 45 using mounting clamps 60 (see FIGS. 11 and12). Protector member 70 is specifically contoured for the anterioraspect of tibia 10 (FIG. 11) and protector member 75 is specificallycontoured for the posterior aspect of tibia 10 (FIG. 12). Each protectormember 70, 75 can be radiolucent, with a radiographic marker running thelength of its mid-section to show the direction of the bone cut, forexample, under fluoroscopy, prior to beginning the bone resecting phase.

FIGS. 11 and 12 show cutting blade 65 passing through cutting slot 50(FIG. 9) in cutting guide 45 and into tibia 10. As cutting blade 65passes through cutting slot 50 and cuts the bone along the desiredangle, protector members 70, 75 ensure that cutting blade 65 does notinadvertently cut soft tissue and neurovascular structures anterior andposterior to the bone.

Mechanical Jack 90

Referring next to FIGS. 13-16 and 16A, once the bone cut is made,cutting guide 45 and protector members 70, 75 can be removed. Amechanical jack device 90 (FIG. 13) is then secured to positioning guide20. More particularly, two metal plates 95, 100 (of mechanical jack 90)are inserted into the bone cut in tibia 10, and mechanical jack 90 isthen secured to positioning guide 20. Mechanical jack 90 may then beused to open metal plates 95, 100 relative to one another so as tocreate the desired osteotomy void in tibia 10.

Alternatively, and looking now at FIG. 14, protector members 70, 75 maybe left in place within the incision while mechanical jack 90 is securedto positioning guide 20 and operated to open the bone cut in tibia 10.

Mechanical jack 90 is opened by turning a worm gear end 115 with ascrewdriver or other instrument (not shown). See FIGS. 15, 16 and 16A.Calibrations (not shown) preferably disposed on strut 120 (FIG. 15)indicate the opening or angle (or height) of void 110.

Once the osteotomy wedge has been opened to a desired position, either(i) the entire mechanical jack 90 is removed, or (ii) just the frontportion 105 of the mechanical jack 90 is removed, leaving blades 95, 100within the bone so as to hold open the osteotomy void 110 in tibia 10.

Multi-Part Implant 125

Once mechanical jack 90 has been used to open the osteotomy void 110 intibia 10, a multi-part implant 125 is deployed in the void so as tosupport the bone in the desired position during healing.

More particularly, and looking now at FIGS. 17-27, there is shown amulti-part implant 125 which may be used to hold open the osteotomy void110. Preferably, multi-part implant 125 comprises an anterior part 130,a posterior part 135, and a medial or base part 140 (see FIGS. 17-20).Anterior part 130, posterior part 135 and base part 140 are preferablyassembled together in-situ to form the complete multi-part implant 125.More particularly, slotted fittings 145 (formed by a first portion 150on each of anterior part 130 and posterior part 135, and a secondportion 155 on each end of base part 50) serve to connect anterior part130 and posterior part 135 to base part 140. While fittings 145 areshown in the drawings to comprise a male member on base part 140 andfemale member on anterior part 130 and posterior part 135, thisarrangement could be reversed, or alternative fittings or connectors maybe used. Implant 125 is preferably deployed in osteotomy void 110 by (i)first separately positioning anterior part 130, posterior part 135, andbase part 140 in the void, and (ii) then joining anterior part 130,posterior part 135, and base part 140 together (using slotted fittings145).

A set of fixation holes 160 (FIG. 23) are provided in base part 140 tosecure the assembled implant 125 to the tibia using fixation screws 175(FIG. 26). Base fixation holes 160 are preferably disposed at an anglerelative to one another so as to direct at least one fixation screw 175into tibia 10 on each side of void 110. More particularly, boneinterface surface 140A (FIG. 23) of base part 140 engages one of thebone surfaces forming void 110 of tibia 10. Fixation hole exit 160Aemerges through surface 140A so as to allow a fixation screw 175 (FIG.26) to pass into the surrounding tibia bone 10. Fixation screw 175enters tibia 10, whereby to fix base 140 (and hence the entire implant125) to tibia 10.

Anterior part 130 and posterior part 135 of implant 125 preferablyinclude injection ports 165 (FIG. 22) leading to channels 170. Channels170 extend through anterior part 130 and posterior part 135 and exit onthe upper and lower surfaces of anterior part 130 and posterior part135, whereby to communicate with the part/bone interface. Injectionports 165 permit material (e.g., bone cement, bone paste, growthenhancers, etc.) to be delivered to the part/bone interface.

Anterior part 130, posterior part 135 and/or base part 140 may be formedout of one or more resorbable materials, whereby they may be resorbedinto the host bone.

In one preferred form of the invention, anterior part 130, posteriorpart 135 and base part 140 are all formed out of a biomaterial and/or abiocomposite that resorbs into the host bone, with anterior part 130 andposterior part 135 being formed so that they resorb faster than basepart 140. By forming base part 140 out of a longer-lasting biomaterialand/or biocomposite, base part 140 can provide lasting strength andsupport for the osteotomy to ensure optimal bone growth within void 110.

Preferably the area within osteotomy void 110 is filled with bonecement, bone paste, growth enhancers, etc. during the procedure, so thatthe osteotomy void 110 bounded by multi-part implant 125 will createbone or bony ingrowth over time. This may be done (i) after anteriorpart 130 and posterior part 135 are deployed in the osteotomy void, and(ii) before base part 140 is secured to parts 130 and 135.Alternatively, additional through holes (not shown) may extend throughbase part 140, whereby to permit the interior of osteotomy void 110 tobe accessed even after the multi-part implant is assembled in theosteotomy void.

Osteotomy Procedure

An osteotomy procedure may be conducted using a medial-to-lateralapproach or an antero-medial approach.

(i) Medial-To-Lateral Approach

Looking next at FIGS. 28-31, there is shown a medial-to-lateral approachwith a specified depth of an osteotomy cut.

With prior art systems and methods, using the medial-to-lateral approachmay allow the surgeon to more easily obtain the correct AP tibial slope,which is crucial to knee stability. In addition, with prior art systemsand methods, the medial-to-lateral approach may allow the surgeon tomore easily control the cutting plane from posterior to anterior.

However, in practice, the medial-to-lateral approach can be difficult toexecute with prior art systems and methods due to the presence of softtissue structures such as the medial collateral ligament attachmentsite. Therefore, with prior art systems and methods, it may be preferredto use an antero-medial approach.

(ii) Antero-Medial Approach

Referring next at FIGS. 32-34, with prior art systems and methods, theantero-medial approach may present difficulties in maintaining acontrolled cutting plane. With prior art systems and methods, it isgenerally not possible to ensure a cutting plane that is offset at afixed angle to the sagittal plane so as to maintain the existinganterior-posterior (AP) tibial slope. Essentially, with prior artsystems and methods, which are hand-guided and directed, the actualcutting plane is made by means of two or more angular adjustments in anoblique fashion to the sagittal plane while the bone is being resected.Once the osteotomy is opened and the osteotomy void is created, it isthis offset and oblique angles that make it difficult to maintain thepatient's anatomical tibial slope.

If the anatomical AP slope is not maintained or controlled, the patientmay experience postoperative knee instability. In addition, severalsurgeons have begun to address knee instability problems (due to kneeligament laxity or damaged knee ligaments) by making planned adjustmentsto the patient's AP tibial slope. Such important planned changes to theslope must be accurate and carried out methodically.

When performing an opening wedge osteotomy, and more specifically a hightibial osteotomy, there are a number of important elements that need tobe executed by the surgeon in order to achieve a positive surgicaloutcome.

One important element is to maintain the anterior-to-posterior (AP)tibial slope.

Another important element is to maintain and control the plane in whichthe bone cut is made.

Still another important element is to provide a fixation system thatpromotes physiologic healing and regeneration of new bone in order toprovide for a long lasting osteotomy.

Yet another important element is to support the osteotomy void duringhealing in order to maintain the AP tibial slope and protect the bonegrafting materials used to enable new bone growth.

In prior art systems and methods for carrying out an antero-medialapproach, the above criteria are generally not easily met. As a result,the published literature generally teaches that the best approach formaking the bone cut is a direct medial-to-lateral approach.

Significantly, the present invention provides an improved system andmethod for an opening wedge osteotomy using an antero-medial approach.

(iii) Preferred Method

Referring next to FIG. 31, there is shown a medial-to-lateral approachwhich, as noted above, is discussed in much of the medical literature asbeing the “best” approach to make a bone cut in a sagittal plane.However, in practice, this can be a difficult procedure due to theattachments of the medial collateral ligaments.

Looking now at FIG. 33, the present invention preferably uses anantero-medial approach, with the position of the bone cut beingestablished through the use of the positioning guide 20 and cuttingguide 45, as discussed above and as will hereinafter be discussed infurther detail below.

Referring now to FIGS. 35-37, there are a number of documentedtechniques by which the surgeon may determine the precise correctivealignment that is to be established by the osteotomy being performed.All of the techniques commonly used generally require full lengthstanding AP and lateral radiographs. Typically, a line 200 is drawn fromthe center of the femoral head 205 to the center of the tibial-talarjoint 210 (FIG. 35). This represents the patient's present mechanicalaxis. Another line 215 is drawn from the center of the femoral head 205to a point 220 located at 62.5% of the width of the proximal tibia inthe lateral knee joint. A third line 225 is drawn from the center of thetibial-talar joint 210 to the same point 220 in the lateral knee joint.An angle 230, formed by the intersection of the two lines 215 and 225,determines the degree of correction required to return the patient'smechanical axis to the point of intersection on the lateral side.

Next, the surgeon must determine the cutting depth of the osteotomy andthe properly sized, slotted cutting guide 45 to be used for theprocedure.

Referring now to FIG. 36, on a radiograph, the surgeon first draws aline 235 from a portion 240 of the medial cortex of the tibia to thelateral cortex that is 1 cm below the joint line. Next, a line 250 isthen drawn that is (i) perpendicular to line 235, and (ii) equal to, orgreater than, 1 cm from lateral cortex 245 of tibia 10. Point 255, whereline 235 and line 250 intersect, marks the appropriate depth of the bonecut to be made across tibia 10. A distance 260 is measured from themedial cortex 240 to the intersecting point 255. Distance 260 is themaximum distance (or depth) of the bone cut which is to be performed.

Next, the surgeon calculates the point of entry for the osteotomy bonecut. A line 265 is drawn from the intersecting point 255, angledinferiorly but remaining above the anterior tibial tubercle 270, to apoint 275 which lies on the vertical line dropped from theaforementioned portion 240 of the medial cortex. The initial point ofentry 280 (FIG. 37) for performing the resection lies on line 265, andcan be calculated as the distance 285 between point 240 and point 275.

The oblique resecting angle 290 is calculated from the inside wedgeangle formed by points 240, 255 and 275 (FIG. 36).

Through such preoperative planning, the surgeon can calculate therequired positioning of the bone cut which will be used to form anosteotomy void which, in turn, will be used to effect the correctiveangle 230 (FIG. 35). More particularly, prior to initiating theosteotomy, the surgeon can calculate: (i) the point of entry 285 on themedial cortex for the bone cut; (ii) the depth of the resection 295; and(iii) the oblique angle 290 of the bone cut across tibia 10 to remainabove anterior tibial tubercle 270.

Once the surgeon has identified the proper attributes of the bone cut,the surgeon then uses the method and apparatus of the present inventionto effect the bone resection. More particularly, the surgeon preferably:

-   -   (i) attaches positioning guide 20 to the proper location on        patient's tibia;    -   (ii) selects the proper cutting guide 45 to be attached to        positioning guide 20, whereby to define the target slope (or        plane) of the cut to be made in the tibia;    -   (iii) selects the proper protector members 70, 75 to be attached        to the cutting guide 45, whereby to protect the soft tissue and        neurovasculature structures surrounding the tibia;    -   (iv) secures the cutting guide 45 to positioning guide 20, and        then secures protector members 70, 75 to the cutting guide 45;    -   (v) selects the proper cutting blade 65 to be used in the        procedure, whereby to define the proper depth of the cut to be        made in the tibia;    -   (vi) passes cutting blade 65 through guide slot 50 formed in        cutting guide 45 and through tibia 10, following the pathway 65A        established by cutting guide 45, until the cut has been made to        the proper depth;    -   (vii) withdraws cutting blade 65;    -   (viii) uses mechanical jack 90 to open the cut in the bone to        the proper angle; and    -   (ix) inserts the multi-part implant 125 into the osteotomy void        110 created in the bone, whereby to hold the resected tibia in        the proper configuration.

Preferably, bone cement or bone paste, etc. is inserted into theinterior of the osteotomy void, within multi-part implant 125, wherebyto facilitate strong bone growth and/or bony ingrowth; and preferablybone cement is injected into the implant/bone interface to help furthersecure the multi-part implant to the bone.

Significantly, with the present invention, the bone cut is made easilyand reliably using an antero-medial approach, while providing excellentprotection of the soft tissue and neurovasculature structuressurrounding the tibia. Furthermore, osteotomy stabilization is achievedthrough the use of an implant device that provides stability about theosteotomy site while allowing the direct contact of bone graft materialwith native bone within the open wedge osteotomy. Significantly, thepresent invention also allows for the necessary physiologic compressionand stimulation required to promote new tissue and bone growth throughthe bony void. This is in sharp contrast with prior art open wedgeosteotomy systems, which use fixation plates and screws to maintain andsupport the corrective wedge opening; such systems do not allowbeneficial physiologic compressive forces to act on the bone/graftinterfaces. This can lead to nonunion osteotomies and failedcorrections.

As noted above, the bone cut typically penetrates to within a centimeteror so of the lateral side of the tibia. In some circumstances, thesubsequent opening of the osteotomy void may result in cracking at thefar bone hinge. Therefore, and looking now at FIG. 34, it may bedesirable to pass a small bone cutting burr along the far edge of thebone hinge, so as to remove possible stress risers that may exist andhelp reduce the risk of fracture when opening the osteotomy cut intowedge void 110. To the extent that the method includes such astress-riser-reduction step, it is preferably done after making the bonecut and before opening the osteotomy void.

Alternative Mechanical Jack 300

Referring now to FIGS. 38-47, in an alternative form of the invention, amechanical jack 300 may be used in place of the aforementionedmechanical jack 90.

More particularly, mechanical jack 300 preferably comprises two plates305, 310. Plate 305 is disposed in the tibial bone cut in a superiorposition, and plate 310 is disposed in the tibial bone cut in aninferior position. As seen in FIG. 38, plates 305, 310 may comprise oneor more varying shapes 315, 320, 325, etc. A preferred shape for plates305, 310 is oblong, measuring about 15-20 mm across and about 40-70 mmlong. Plates 305, 310 are preferably configured to extend substantiallythe entire depth of the bone cut, in order to provide ample support whenopening the bone. Both plates 305, 310 connect or join to each other attheir distal ends 330 and allow their proximal ends 335 to open relativeto one another, whereby to form an opened wedge.

Plates 305, 310 are coupled with a mechanical device 340 (FIG. 44) thatprovides a deliberate degree of opening of the bone cut. Mechanicaldevice 340 preferably comprises a rail system 345 and an actuationdevice 350 (FIG. 44). At the proximal end 335 of each plate 305, 310 isa male projection 355 that allows attachment of the plates to actuatorhousing 360. Actuator housing 360 preferably comprises a rectangularshaped plate 365 that houses at least one sliding member 370 withratchet teeth 375. Sliding member 370 preferably comprises calibrationmarkings 380 in specific measurements. Calibration markings 380 may bein various units of measurement including, for example, angle in degreesor millimeters of opening. Actuator housing 360 preferably measuresapproximately 1 cm wide×2 cm long×3-5 mm deep. Actuation device 350 isrotatably fixed to housing 360 so that teeth 385 engage teeth 375 onsliding member 370. As a result of this construction, when actuationdevice 350 is rotated, it effectively moves the sliding member 370 up ordown (depending on the direction of rotation), whereby to open or closethe plates 305, 310 relative to one another. Sliding member 370preferably measures about 5 mm wide×2 cm long×2-4 mm thick, and has afemale-type connector 390 (FIG. 44) positioned in the center that fitswith the male-type projection 355 of inferior plate 310;correspondingly, housing 360 preferably has a female-type connector 395that fits with the male-type connector 355 of superior plate 305.Preferably, a locking pin 400 is also provided which, once pushedinward, fits into gear teeth 375 of sliding member 370, whereby toprevent movement of sliding member 370.

In an alternative preferred embodiment (not shown), a circular actuatoris configured to drive two sliding members in opposing directionsrelative to one another so as to open up or close down plates 305, 310with respect one another.

Referring now to FIGS. 45-47, operation of mechanical jack 300 isillustrated. More particularly, plates 305, 310 are slid into apreviously-made bone cut 405. A hand driver tool 410 is preferably usedto rotate the actuator device 350 in a direction that begins to openplates 305, 310 into a wedge configuration. As the wedge is opened, thesurgeon notes the position of calibration markings 380 on sliding member370 (FIG. 46) and opens the plates 305, 310 to the desired angle of bonereconfiguration (which was determined preoperatively). Once thecorrective angle is achieved, locking pin 400, which is preferablylocated on the side of actuator housing 360, is slid into place so as toprevent movement of sliding member 370. Thereafter, the osteotomy may beconducted in the manner previously discussed, i.e., the surgeon insertsthe multi-part implant 125 into the opening in the bone, whereby tostabilize and secure the open wedge osteotomy.

Alternative Implants 500

In alternative embodiments of the present invention, and referring nowto FIGS. 48-60, 61-68, 69-74, 75-78, 79-87 and 88-89, the osteotomyprocedures described above may be practiced using an alternative implant500 substituted for the multi-part implant 125 described above.Preferably, the alternative implant 500 utilizes a design that framesthe perimeter of the osteotomy void 110 and acts as a strut forsupporting tibia 10 at the corrective angle 505 (FIG. 48).

As with multi-part implant 125, the overall design of substitute implant500 is wedge-shaped (FIG. 49), with a leading (or distal) edge 510 thatfits into the closed (or distal) portion of the open wedge osteotomy,and a base (or proximal) side 515 that fits into the opening (orproximal side) of the open wedge osteotomy. Implant 500 comprises twoopposing side walls 520 (FIG. 50), each preferably measuring about 2-5mm wide, with their surfaces framing the perimeter of the bony void withan open inside perimeter 525, the leading side or edge 510, and the highbase side 515. Base 515 preferably has a height of about 2-10 mm orgreater. In a preferred embodiment of the present invention, base 515has a slightly wider width than distal end 510, and base 515 is radiusedat its outboard sides (FIG. 51). The length of implant 500 approximatesthe depth of the osteotomy, typically measuring about 40-70 mm. Implant500 is configured so that, overall, it closely follows the perimeter oftibia 10 across the osteotomy void 110.

Implant 500 may utilize a variety of shapes and constructs in additionto those shown in FIGS. 49-51, as will be described below.

Referring next to FIG. 51, in a preferred embodiment of the presentinvention, implant 500 comprises a solid wedge frame implant 530. At theleading (or distal) end 510, the height of implant 500 decreases ortapers to conform to the closed portion of the tibial osteotomy. At base(or proximal end) 515, the implant is taller to conform with the larger,exposed opening of the wedge osteotomy. Implant 530 may be of the sameor varying (e.g., widening) width as it extends from leading end 510 tobase 515. Base 515 of implant 530 preferably includes one or more holesor openings 535 extending completely through base 515. Openings 535allow material to be introduced into the interior of the implant, e.g.allograft or autograft bone, demineralized bone substitutes, other bonegraft material preferably having osteoinductive or osteoconductiveproperties, bone cement, or other desired materials. Preferably, implant530 has four continuous or joined sides including the base 515, the twosides 520, and a floor portion 540; the four components together definethe open perimeter 525.

Referring now to FIGS. 52-55, there are shown single-piece wedge frames545, 550, 555, and 560, respectively. These four frames are formed outof three (a base and two sides) continuous or joined portions, but donot have a leading (i.e., distal) edge, and have an open bottom (i.e.,they omit the floor portion 540).

Referring now to FIGS. 56-60, in other preferred embodiments of theinvention, there are provided multi-part wedge frames 565, 570 and 575,which comprise a base 515 and two opposing side walls 520. In the caseof implant 565, base 515 may be formed in two halves, with one halfconnected to each side wall 520. In the case of the wedge frames 570(FIG. 57) and 575 (FIG. 58), base 515 may comprise two halves, oneconnected to each side wall 530, and a connecting plate connecting thetwo base halves together. The various parts making up frames 565, 570and 575 are preferably inserted separately into the osteotomy void 110and, in the case of wedge frames 570 and 575, which include a connectingbase member, secured together. Preferably, the insertion takes placeposterior side first, then the anterior side and finally, in the case offrames 570 and 575, the connecting base last. Base 515 is preferablyattached to sides 520 at 580, using screws, rods or any other fasteningmeans, which are preferably of the same material as the implant.

A distinct advantage of the multi-part implant 565, 570, and/or 575, aswell as the multi-part implant 125 described previously, is the abilityto effect intended changes to the tibial slope by inserting one wall 520of a specific height and size, and then inserting an opposing wall 520of a potentially different height and size. These changes can becalculated preoperatively or may be a result of an intra-operativeassessment by the surgeon.

Looking next at FIGS. 61-68, any of the aforementioned implants 500, aswell as the aforementioned multi-part implant 125, can includeprojections, ridges or protrusions 585 (hereinafter sometimescollectively referred to herein as “projections 585”) on its boneinterface surfaces. These projections 585 are shaped in such a way as toallow for easy insertion of implant 500 into the osteotomy void 110 butprevent migration of implant 500 once fitted in place.

The various wedge shaped implants 500 may be formed out of a metal(e.g., titanium or stainless steel) or any other biocompatible materialor polymer, absorbable or non-resorbable, that may or may not beosteoinductive or osteoconductive.

Looking next at FIG. 68, the base 515 of implant 500 can be furthersecured to tibia 10 with the placement of screws or rods 590, preferablyangled through base 515 into tibia 10. Screw or rods 590 may be directedboth superiorly and inferiorly into the tibia. Furthermore, base 515 ofthe implant can also function as a secure fixation system, therebyreplacing the traditional static fixation plate and bone screws.

As noted above, base 515 can be made of a metal material, abioabsorbable material, a biocomposite material that may or may notpromote bony integration, or a combination of biocomposite materials andmetal in order to add strength to the eventual loading of the osteotomysite. It may be preferable to provide a base member that providessufficient weight-bearing support and strength through the naturalhealing period of the osteotomy site and then begin to resorb over time,thereby preventing or reducing the effects of stress shielding of therepair and new bone growth. Such a resorbable base member, inconjunction with a resorbable, solid walled implant, provides activecompression across the osteotomy site, thereby promoting faster andstronger healing of the osteotomy site.

Looking now at FIGS. 69-74, in other preferred embodiments of thepresent invention, the wedge 500 may take various configurations whichincorporate channels 595 extending through components for deliveringbiocompatible adhesive glues, bone cements, growth factors or graftingmaterials to the bone contacting surfaces 600. These materials arepreferably resorbable. The provision of channels 595 in the implant isan important feature, since (i) it may permit the implant to be bettersecured within the osteotomy void 110 when glues or cement-likematerials are delivered through channels 595, and (ii) it may facilitateformation of beneficial bony ingrowth when growth factors or graftingmaterials are delivered.

When adding nonresorbable cements or glues to secure the implant, it maybe advantageous to allow natural cortical bone growth and new boneintegration into and through the surfaces of the wedge implant; this mayprovide for better long-term security and stronger healing of theosteotomy site. As such, these adhesives and/or bone cement materialscan be delivered through a narrow tube-like device 605 (FIG. 69) thatincorporates openings 610 that align with channels 595 running tosurface 600 of implant 500. Once adhesive or cement-like material 612 isdelivered through tube device 605, into and through channels 595, tosurface 600 of implant 500 and native bony surface of tibia 10, tubedevice 605 is withdrawn. Such a delivery approach provides for areas ofadhesion while allowing native bony contact with surface 600 of implant500. Also, by delivering material 612 through tube device 605, which mayrun the length of implant 500, and then withdrawing tube 605, more ofimplant 500 may integrate with new bone growth while using the anefficient amount of adhesive or cement material to secure implant 500.

Referring now to FIGS. 75-78, in a preferred embodiment of the presentinvention, at least one implant/bone interface channel 615 is formed inimplant 500. When using resorbable adhesives or bone cements, it may beadvantageous to have material flow or be delivered within an open cavitythat follows at least a substantial portion of the entire contactsurface between implant 500 and bone 10 (FIG. 77). This configurationgenerally provides increased strength of fixation and improvedattachment of implant 500 to bone 10. As such, after implant 500 isinserted and positioned, adhesive material is injected/delivered intoimplant/bone interface channel 615. Base 515 is preferably attached totibia 10 with either screws 590 (FIG. 78) or with adhesive (not shown).

Three-Part Implant and Trial Procedure

Referring next to FIGS. 79-83, with the vertical height of actuatorhousing 360 fixed in place, the surgeon may insert a trial implant 500Afor the posterior side and the anterior side of wedge frame implant 500(FIG. 80). To this end, there are preferably provided a number ofincrementally-sized trial stabilizers that the surgeon uses to attainthe best anatomical fit for implant 500, and to ensure properpositioning for the attachment of the base 515 that fits into osteotomyopening 110.

Once the properly sized anterior side 520 and the properly sizedposterior side 520 of implant 500 are inserted, actuator 350 is unlockedand rotated so as to slightly loosen corrective device 340 (FIG. 44).Actuator housing 360 is then removed from the corrective plates, andeach plate is removed (FIG. 81). Bone graft and/or bone filler materialcan be introduced into the osteotomy, filling much of void 110. Theappropriately sized base wall 515 of wedge implant 500 (FIG. 82) isfitted into wedge opening 110. Base 515 is then secured to side walls520 through the use of the threaded fasteners 580. Additional bone graftmaterial is then introduced through openings 535 in base 515 and thebony void is filled.

Referring now to FIG. 83, stabilization about the osteotomy site isachieved with the wedge-shaped implant 500 providing stability about theosteotomy site while maintaining the desired corrective angle. Byallowing the direct contact of bone graft material with the bony cutsurface of the osteotomy, within the perimeter of the wedge implant, thenecessary physiologic compression and stimulation required to promotenew tissue and bone growth through the bony void is provided.

FIGS. 84-87 show another depiction of the three-part wedge-shapedimplant and the trial procedure described herein and illustrated inFIGS. 79-83.

One-Part Implant and Trial Procedure

Referring now to FIGS. 88 and 89, there is shown a one-part,open-bottomed, wedge-shaped implant 545A. Again, the surgeon uses atrial implant 545A and inserts the trial implant 545A into osteotomyopening 110 to ascertain precise fit and sizing of trial implant 545A.Trial implant 545A is removed-and the properly-sized implant 545 (FIG.89) is inserted into the osteotomy void 110. The preferred bone graftmaterial is introduced through the openings 535 of the base side 515 andthe bony void is filled.

Again, stabilization is achieved with the wedge-shaped implant 545providing stability about the osteotomy site while maintaining thecorrective angle. By allowing the direct contact of bone graft materialwith the bony cut surface of the osteotomy, within the perimeter of thewedge implant, the necessary physiologic compression and stimulationrequired to promote new tissue and bone growth through the bony void 110is provided.

Alternative Resection System 700 Comprising Two Blade Positioning Guide705 and Resection Guide 710

Referring next to FIGS. 90-109, in an alternative embodiment of thepresent invention, there is shown a resection system 700 comprising atwo blade positioning guide 705 and a resection guide 710 for creating abone cut 715 (FIG. 110).

The osteotomy positioning guide 705 comprises two opposing blades 720,725 (FIG. 90).

A posterior blade 720 (FIG. 91) is configured for the posterior aspectof the proximal tibia 10, and an anterior blade 725 (FIG. 92) isconfigured for the anterior aspect of the proximal tibia 10. Each blademember 720, 725 has a corresponding radius of curvature that allows itto fit closely to the surface of tibia 10 (FIGS. 91 and 92) into whichthe transverse resection 730 is to be performed (FIG. 93). Each blademember 720, 725 is preferably wide enough to protect soft tissue andneurovasculature structures during the osteotomy procedure. Each blademember 720, 725 preferably has a small handle 735 (FIG. 90) integralwith the member itself. Handle 735 allows easier deployment andpositioning of each blade member 720, 725 around the proposed osteotomysite. The blade members 720, 725 can vary in length, width and thicknessbut, generally, will measure approximately 6-8 cm in length, 3-5 cm inwidth and 1-3 mm in thickness. Each individual blade 720, 725 isinserted through the incision site and guided around tibia 10. Superiormargins 740 of each opposing blade 720, 725 can be adjusted in order toalign blades 720, 725 with the anterior-posterior slope 745 of the tibia(FIG. 97). Once each blade member 720, 725 is properly positioned, theblade is secured in place using fixation holes 750 (FIG. 96) andfixation screws or pins 755. Fixation hole 750 on each blade member 720,725 is preferably located about 1-3 cm below superior margin 740.However, each matching set of blade members 720, 725 preferably hasequal distances from superior margin 740 to fixation hole 750.

Osteotomy guide 705 is preferably radiolucent, so as to allow thesurgeon to take radiographs or use fluoroscopy with blade members 720,725 in place.

In one embodiment of the present invention (not shown), osteotomypositioning guide members 720, 725 are expandable once placed through anincision.

Resection guide 710 is shown in more detail in FIGS. 98-103. Resectionguide 710 comprises at least one oblique cutting slot 760, and isconfigured for attachment onto the fixation screws or pins 755 of blademembers 720, 725.

When bone resection guide 710 is attached to tibia 10 using fixationscrews 755, cutting slot 760 is properly located relative to theanterior-posterior slope 765 of tibia 10 (FIG. 100). Desired changes inslope 765 are preferably introduced by removing and re-positioning oneor both of the screws 755 holding blade members 720, 725 and resectionguide 110 to the tibia. Resection guide 710 has a corresponding radiusof curvature for its body that allows a close fit to a bone surface 770(FIG. 101). Preferably, the thickness or distance from bone surface 770to the opposing side of resection guide 710 is such that a resectinginstrument 775 (such as a bone saw cutting blade 775) cuts uniformlyacross tibia 10 at the same cutting depth. Preferably, there is provideda system of sized resection guides 710 with cutting slots 760 thatcorrelate to the resection point of entry on the medial side of the knee(distance 285 below the joint line, as obtained from a preoperativeradiograph, see FIG. 36) and to the planned oblique angle 290 of theresection (see FIG. 36) in order for resecting instrument 775 (FIG. 101)to remain superior to anterior tibial tubercle 270 (see FIG. 36). Theseresecting guides 710 preferably range in overall size from about 2-5 cmacross tibia 10 (from anterior to posterior), about 3-5 cm in length andabout 5-10 mm in thickness. Cutting slot 760 is preferably located about3-5 cm below the joint line (FIG. 103), with an oblique cutting angle290 of 20-60 degrees (FIG. 102).

Osteotomy Procedure Using Alternative Resection System 700 (Two BladePositioning Guide 705 and Resection Guide 710)

A routine knee arthroscopy is generally carried out to remove any loosebodies and to perform general joint debridement. During the arthroscopy,other repair procedures may be carried out such as meniscus repair,cartilage repair or tissue regeneration procedures. Following thearthroscopy, an antero-medial skin incision is made over the tibia 3-5cm below the joint line from the anterior tibial tubercle to thepostero-medial border of the tibia.

Referring now to FIGS. 104-110, a kit including resection system 700 ispreferably opened at the surgical site. System 700 comprises the blademembers 720, 725 and the section guide 710 that provide for a preciseslope or plane of bone cut 715 (FIG. 110), and the protection ofsurrounding neurovasculature structures during the cutting operation.The two opposing blade members 720, 725 include the posterior blade 720and the anterior blade 725, which are inserted through the incision siteand guided around the bone 10 targeted for the osteotomy (FIG. 104). Thepes anserinus is retracted, allowing visualization of the superficialmedial collateral ligament (MCL). The MCL is retracted superiorly toallow the insertion of posterior blade member 720 below the medialcollateral ligament and around the postero-medial border, hugging theposterior aspect of the knee. Posterior blade 720 reaches laterally tothe medial border of the fibula and rests against fibular head 780 (FIG.105). Anterior blade member 725 is inserted under the patella tendon andreaches to antero-lateral border 782 of the tibia 10 (FIG. 106). Eachblade member 720, 725 has a corresponding radius of curvature thatallows it to fit closely to the bone surface into which the osteotomywill be cut. These blade members 720, 725 can vary in length, width andthickness but, generally, will measure approximately 5-8 cm in length,3-5 cm in width and 1-3 mm in thickness. Superior margins 740 of eachopposing blade 720, 725 are aligned along tibial plateau 785 to followthe natural anterior-posterior slope or plane of the plateau. However,the surgeon can also adjust the position of either blade 720, 725 toaffect a specific desired tibial slope change. The joint line canfurther be identified with the placement of Keith needles at region 790(FIGS. 105 and 106) through the knee capsule and under the meniscus.This use of Keith needles aids the surgeon in properly aligning eachblade member along the joint line. Each blade member 720, 725 is securedin place through its respective fixation hole 750 with the providedfixation screw or pin 755.

Next, a proper slotted cutting guide 710 is chosen. Preferably, there isprovided a system of cutting guides 710 that correspond to overallsizing (i.e. small tibia, medium tibia, or large tibia) with eachcutting guide body having a radius of curvature that allows it to fitclosely to the bone surface. Based upon the preoperative planningprocedure, the surgeon chooses the appropriately sized cutting guide710, matching the preoperatively measured distance 285 below the jointline for the point of entry (FIG. 103) with the oblique cutting anglerequired to remain above tibial tubercle 270 (FIG. 36). The surgeonattaches or connects cutting guide 710 to the fixation screws or pins755 of blade members 720, 725 (FIG. 107). The exact placement of bonecut 715 (FIG. 110) is precisely defined, incorporating the planned planeor anterior-posterior slope of the cut. Cutting guide 710 is preferablyconfigured with a thickness or distance from the bone surface to theopposing side such that cutting blade 775 cuts uniformly across tibia 10at the same cutting depth. The surgeon fits a blade stop 795 (FIG. 109)onto cutting saw blade 775 to mark the required distance of cut 715 asdetermined preoperatively. With protection of neurovasculaturestructures provided by blade members 720, 725, with the appropriatecutting guide 710 attached, and the appropriate cutting distancemeasured and ensured via blade stop 790, the cutting operation can besafely performed through slot 760 of the cutting guide 710 (FIGS. 108and 109), effectively completing the osteotomy or bone cut through thebone cortices, leaving a minimum 1 cm bone hinge 800 on the lateralaspect of the proximal tibia 10 (FIG. 110). The slotted cutting guide710 is then removed, leaving the positioning guide blade members inplace.

Preferably, and following the formation of the osteotomy cut via a bonesaw, the surgeon ensures that the bone cortices are cut by using a thinosteotome and probing the cortices inside the bone cut. Once assuredthat the bone cortices are cut, the surgeon removes the blade members720, 725. Next, bone cut 715 (FIG. 110) is opened using an opening wedgedevice such as the mechanical jack 90 (FIGS. 13-15) or the alternativemechanical jack 300 (FIGS. 44-47). The wedge is opened until the desiredangle is achieved. At this point the surgeon preferably slowly opens thewedge another 2 mm or so to allow for easier insertion of the wedgeframe implant.

With the desired corrective angle achieved, the surgeon then prepares tostabilize and secure the open wedge osteotomy and insert bone graftmaterial into the osteotomy void. This may be done using anappropriately sized implant such as the multipart implant 125 (FIGS. 19and 20) or an alternative wedge osteotomy implant 500 (FIGS. 48-60,61-68, 69-74, 75-78, 79-87 and 88-89) disclosed above. Each implant issized according to the opening height of the wedge osteotomy and thedepth of the cut. From the preoperative planning exercise, the surgeonmost often has determined the correct implant size. However, the surgeonmay also elect to use an implant trial to determine correct implant sizeas well.

Expandable Wedge Implant 805

Referring now to FIGS. 111-125, in another preferred embodiment of thepresent invention, there is shown an expandable wedge implant 805comprising two opposing sides 810 which are coupled with an openingdevice such as the mechanical jack 90 (FIGS. 13-15) or alternativemechanical jack 300 (FIGS. 44-47) to create an open wedge osteotomy.

Expandable wedge implant 805 comprises two opposing sides 810 (FIG. 112)whose surfaces frame the perimeter of the bony void and preferablycreate an opening 815 within the perimeter of sides 810 (FIG. 112). Abase side 820 fits into the opening of the wedge osteotomy and isattachable to sides 810. Each one of the sides 810 is transversely split825 along its length to form two opposing frame members 830, 835.Opposing frame members 830, 835 of each side 810 are connected to oneother with an expandable material 840, e.g., a flexible sheet ofbiocompatible material. When the two frame members 830, 835 are spreadapart within a bony void (or are separated within a bone cut to create abony void), the expandable material 840 forms a containment systemaround the perimeter of implant 805 so as to hold graft or bone fillermaterials within implant opening 815.

The transversely split sides 810 can be continuous in form at leadingend 845 (FIG. 113); or split sides 810 can be connected or joined atleading end 845 (FIG. 114); or split sides 810 can be connected withexpandable material 850 at leading end 845 (FIG. 115); or split sides810 can be otherwise hinged at leading end 845 (e.g., with a pivot pin),etc.

Base side 820 preferably includes passageways 855 for attachment of baseside 820 to the ends 860 of transverse split sides 810 with screws, rodsor other fastener (FIG. 116). Base 820 preferably also includes holes oropenings 865 through which bone graft or bone filler materials can beinjected or introduced (FIG. 116). Once injected or introduced, thevoid-filling material expands implant 805 and expandable material 840along the perimeter of the osteotomy with the graft material insidehaving direct contact with the bony surfaces of the osteotomy.

Expandable material 805 is preferably manufactured from, or comprisedof, any expandable biocompatible material. Expandable material 840 ispreferably resorbable or osteoinductive or osteoconductive in nature.

Referring now to FIG. 117, any of the expandable wedge implants 805 mayincorporate projections, ridges or other protrusions 870 (hereinaftersometimes collectively referred to as “projections 870”) on its boneinterface surfaces. Projections 870 are shaped in such a way as to allowfor easy insertion of implant 805 into the osteotomy but preventmigration of the implant once fitted into place.

The expandable wedge implants may comprise metal (e.g., titanium orstainless steel) or other biocompatible material or polymer. Theselected material may be either absorbable or non-resorbable, which mayalso be either osteoinductive or osteoconductive.

Base member 820 of expandable wedge implant 805 preferably providessecure fixation by insertion of bone screws 875 through the base andinto the bone of the femur (not shown) or tibia 10 (FIG. 118). Byallowing base member 820 of implant 805 to function as a secure fixationsystem, thereby replacing the traditional static fixation plate and bonescrews, base member 820 can comprise a metal material, a biocompositematerial that preferably promotes bony integration, or a combination ofbiocomposite materials or biocomposite material with metal in order toadd strength to the eventual loading of the osteotomy site. Preferably,base member 820 is configured to provide sufficient weight bearingsupport and strength through the natural healing period of the osteotomysite and then begins to resorb over time, thereby preventing or reducingthe effects of stress shielding of the repair and new bone growth. Sucha resorbable base member 820 used in the expandable wedge implant 805provides for active compression across the osteotomy site, therebypromoting faster and stronger healing of the osteotomy site. Also, bonescrews 875 used to secure the base member may be formed of the same orsimilar materials as base member 820.

Referring now to FIGS. 119 and 120, transverse split wedge design 805preferably also includes channels 880 through its solid materialsurfaces for delivering biocompatible adhesive glues, bone cements,growth factors or grafting materials. These materials are preferablyresorbable. The importance of adding channels 880 is to better secureimplant 805 within the osteotomy wedge void when glues or cement-likematerials are delivered; and/or, in the case of adding growth factors orgrafting materials, to promote the formation of bony in-growth to securethe implant.

When adding nonresorbable cements or glues to secure implant 805, it maybe advantageous to allow natural cortical bone growth and new boneintegration into and through the surfaces of the wedge implant; this mayprovide for better long-term security and stronger healing of theosteotomy site. As such, these adhesives and/or bone cement materialscan be delivered through a narrow tube-like device 885 (FIG. 119) thatincorporates openings 885A that align with channels 880 running tosurface 890 of implant 805. Once the adhesive or cement-like material isdelivered through tube device 885 into and through channels 880 to theinterface of implant 805 and native bony surface of tibia 10, tubedevice 885 is withdrawn. Such a delivery approach provides areas ofadhesion while allowing native bony contact with portions of surface890. Also, by delivering material through tube device 885, whichpreferably runs the length of implant 805, and then withdrawing tube885, more of implant 805 is allowed to integrate with new bone growthwhile using an efficient amount of adhesive or cement material to secureimplant 805.

When using resorbable adhesives or bone cements, implant 805 isalternatively configured to have the material flow or be deliveredwithin a cavity 900 that follows the entire contact surface betweenimplant 805 and the bone (FIG. 120). The provision of cavity 900provides increased strength of fixation and security. As such, afterimplant 805 is inserted and positioned, the adhesive material isinjected/delivered into the implant/bone interface cavity 900. Base side820 is then attached with screws or adhesive.

Osteotomy Technique Using Expandable Wedge Implant

Referring now to FIGS. 121-130, following the creation of a bone cut asdescribed above, the surgeon chooses the properly sized expandable wedgeimplant trial 805A (FIG. 121), based upon the preoperative proceduredescribed above and shown in FIGS. 35-37. Trial implant 805A is insertedinto the osteotomy bone cut and the proper sized implant is determined.Trial 805A is removed and the correctly sized implant 805 (without baseside 820) is inserted (FIG. 122).

Next, the wedge opening plate 805 is assembled. An opening wedge platedevice 905 is preferably provided with four attachment points 910 (FIGS.123-125) that are designed to fit into fixation holes 915 (FIG. 122) ontransverse split sides 810. Attachment points 910 provide support toallow the opening of the wedge osteotomy with implant 805 insertedtherein. Plate device 905 is inserted into the bone cut with its fourattachment points 910 inserted into the openings 915 at the ends of thewedge implant 805 (FIG. 124). The surgeon connects two connectorportions 920 of plate device 905 to actuator housing 360 (FIG. 126). Thesurgeon the uses driver tool 410 to rotate actuator 350 so as to beginopening the bony wedge (FIG. 127). As the wedge is opened, the surgeonviews calibrated markings 380 on sliding member 375. The wedge is openeduntil the desired angle is reached. Locking pin 400 is then activated soas to prevent movement of sliding member 375 (FIG. 128). With theactuator housing 360 still in place, the preferred bone graft materialis then introduced into bony wedge void 110. When void 110 is almostfilled with material, actuator 350 is unlocked, and rotated so as toslightly loosen corrective device 300. Actuator housing 360 is thenremoved from plate device 905, being careful not to remove the graftmaterial. The appropriately-sized base wall 820 for wedge implant 805 isthen chosen and fit into the wedge opening (FIG. 129). Base wall 820 isthen secured to side walls 810 through the use of threaded fasteners920. Additional bone graft material may then be introduced throughopenings 865 of base wall 820 of wedge 805 and the bony void is furtherfilled (FIG. 130).

Stabilization is achieved with expandable wedge implant device 805 atthe osteotomy site while maintaining the corrective angle. By allowingthe direct contact of bone graft material with the bony cut surface ofthe osteotomy, within the perimeter of the expandable wedge implant, thenecessary physiologic compression and stimulation required to promotenew tissue and bone growth through the bony void is provided.

It is to be understood that the present invention is by no means limitedto the particular constructions herein disclosed and/or shown in thedrawings, but also comprises any modifications or equivalents within thescope of the invention.

1. An osteotomy implant for supporting an open wedge osteotomy, theosteotomy implant comprising: a first component for disposition in aposterior portion of the open wedge osteotomy; a second component fordisposition in an anterior portion of the open wedge osteotomy; and aconnection device for selectively connecting the first component and thesecond component to one another.
 2. An osteotomy implant according toclaim 1 wherein the connection device comprises a base component havinga first side and second side in opposition to one another, wherein thefirst side is configured for selective attachment with the firstcomponent, and wherein the second side is configured for selectiveattachment with the second component.
 3. An osteotomy implant accordingto claim 2 wherein the base component forms a fixation hole therein soas to allow placement of a fixation device therethrough for anchoringthe multi-part implant to the tibia.
 4. An osteotomy implant accordingto claim 1 wherein the connection device comprises a slotted fittingbetween the first component and the second component.
 5. A multi-partosteotomy implant for supporting an open wedge osteotomy, the osteotomyimplant comprising: a first component for disposition in a posteriorportion of the open wedge osteotomy; a second component for dispositionin an anterior portion of the open wedge osteotomy; a third componentfor disposition in a medial portion of the open wedge osteotomy; a firstconnection mechanism for selectively connecting the first component tothe third component; and a second connection mechanism for selectivelyconnecting the second component to the third component.
 6. A multi-partosteotomy implant according to claim 5 wherein the first connectionmechanism comprises a first slotted fitting formed between the firstcomponent and the third component, and wherein the second connectionmechanism comprises a second slotted fitting formed between the secondcomponent and the third component.
 7. An osteotomy implant according toclaim 6 wherein the first slotted fitting comprising a first maleprojection and a first female recess configured for attachment to oneanother, and further wherein the first male projection extends from oneof the first component and the third component, and the first femalerecess is configured in the other one of the first component and thethird component.
 8. An osteotomy implant according to claim 7 whereinthe first male projection extends from the third component, and thefirst female recess is configured in the first component.
 9. Amulti-part osteotomy implant according to claim 6, wherein the secondslotted fitting comprises a second male projection and a second femalerecess configured for attachment to one another, and further wherein thesecond male projection extends from one of the second component and thethird component, and the second female recess is configured in the otherone of the second component and the third component.
 10. A multi-partosteotomy implant according to claim 9 wherein the second maleprojection extends from the third component, and the second femalerecess is configured in the second component.
 11. A multi-part osteotomyimplant according to claim 5 wherein the first component, the secondcomponent and the third component form a void therebetween whenconnected together, and wherein the void corresponds substantially to acenter region of the open wedge osteotomy.
 12. A multi-part osteotomyimplant according to claim 11 wherein the first component, the secondcomponent and the third component are configured to allow placement ofgraft material into the void.
 13. A multi-part osteotomy implantaccording to claim 12 wherein the first component, the second componentand the third component are configured to allow compaction of graftmaterial in the void.
 14. A multi-part osteotomy implant according toclaim 5 wherein the first component comprises a first wall having afirst set of dimensions, the second component comprises a second wallhaving a second set of dimensions, and further wherein the first set ofdimensions of the first component and the second set of dimensions ofthe second component are different from one another so as to enableaccurate disposition of the AP tibial slope.
 15. A multi-part osteotomyimplant according to claim 5 wherein the first component has a firstsurface and a second surface, the first surface configured for placementin the mouth of the osteotomy void and the second surface configured forplacement adjacent to a bone surface of the open wedge osteotomy, andfurther wherein the first component forms a first channel thereinbetween the first surface and the second surface so as to allowinjection of a material through the first channel, from the firstsurface to the second surface, and provide the material to abone/implant interface formed between the first component and the bone.16. A multi-part implant according to claim 15 wherein the firstcomponent forms a first injection port at the first surface into thefirst channel, and further wherein the first injection port isconfigured to be accessible by a surgeon subsequent to placement of thefirst component adjacent to the bone.
 17. A multi-part implant accordingto claim 16 wherein the first component forms multiple exit ports at thesecond surface.
 18. An osteotomy implant according to claim 15 whereinthe selected material comprises at least one chosen from a groupconsisting of biocompatible adhesive glue, bone cement, biologicmaterial, growth factor, and grafting material.
 19. A multi-partosteotomy implant according to claim 15 wherein the second component hasa third surface and a fourth surface, the third surface configured forplacement the osteotomy void and the fourth surface configured forplacement adjacent to a bone surface of the open wedge osteotomy, andfurther wherein the second component forms a second channel thereinbetween the third surface and the fourth surface so as to allowinjection of a material through the second channel, from the thirdsurface to the fourth surface, and provide the material to thebone/implant interface formed between the second component and the bone.20. A multi-part implant according to claim 16 wherein the secondcomponent forms a second injection port at the third surface into thesecond channel, and further wherein the second injection port isconfigured to be accessible by a surgeon subsequent to placement of thesecond component adjacent to the bone.
 21. A multi-part implantaccording to claim 20 wherein the second component forms multiple exitports at the fourth surface.
 22. A multi-part implant according to claim19 wherein the second channel is configured to allow injection of oneselected from a group consisting of bone glue, cement, biologicmaterial, and grafting material.
 23. A multi-part implant according toclaim 5 wherein the first component has a first resorption rate intobone, the second component has a second resorption rate into the bone,the third component has a third resorption rate into bone, wherein thefirst resorption rate and the second resorption rate are substantiallythe same as one another, and the third resorption rate is substantiallydifferent from the first resorption rate and the second resorption rate.24. A multi-part implant according to claim 23 wherein the thirdcomponent differs from the first component and the second component byat least one chosen from the group consisting of: different biomaterialcomposition from one another; different biocomposite composition fromone another; and different formulation from one another.
 25. Amulti-part implant according to claim 5 wherein the third componentforms a first fixation hole therein so as to allow placement of a firstfixation device therethrough for anchoring the multi-part implant to thetibia.
 26. A multi-part implant according to claim 25 wherein the thirdcomponent forms a second fixation hole therein so as to allow placementof a second fixation device therethrough for anchoring the multi-partimplant to the tibia.
 27. A multi-part implant according to claim 26wherein the first fixation hole has an entry portion and an exit portionon the third component, the first fixation hole defines a firstlongitudinal axis from the entry portion to the exit portion of thethird component, the second fixation hole has an entry portion and anexit portion on the third component, the second fixation hole defines asecond longitudinal axis from the entry portion to the exit portion ofthe third component, and the first longitudinal axis and the secondlongitudinal axis are non-parallel to one another so as to direct thefirst fixation device into a first portion of the tibia and to directthe second fixation device into a second portion of the tibia, with thefirst portion of the tibia and the second portion of the tibia being onopposing sides of the third component.
 28. A multi-part osteotomyimplant according to claim 5 wherein the first component, the secondcomponent, and the third component are each configured for assemblytogether with one another while within a bone cut of the open wedgeosteotomy.
 29. A multi-part osteotomy implant according to claim 5wherein the first component, the second component and the thirdcomponent are each configured for assembly together with one anotherwhile outside of a bone cut of the open wedge osteotomy.
 30. Amulti-part osteotomy implant according to claim 5 wherein the firstcomponent, the second component and the third component are configuredto support a bone cut of the open wedge osteotomy from an anterioraspect thereof to a posterior aspect thereof.
 31. An osteotomy implantfor supporting an open wedge osteotomy, the osteotomy implantcomprising: a leading edge having a first height, a first width, and thefirst height configured for placement into a distal portion of the openwedge osteotomy; a base portion in opposition to the leading edge, thebase portion having a second height, a second width, and the secondheight configured to substantially close a proximal end of the openwedge osteotomy; and two opposing side walls connecting the leading edgeto the base portion, the opposing side walls having a first length equalto the distance from the leading edge to the base portion, and theopposing side walls having a tapered height from the first height of theleading edge to the second height of the base portion.
 32. An osteotomyimplant according to claim 31 further comprising a floor portionextending between the two opposing side walls and from the base portionto the leading edge, and wherein the floor portion has a third height,and the first height of the base portion is greater than the thirdheight of the floor portion so as to form an open portion between thetwo opposing sides.
 33. An osteotomy implant according to claim 31wherein the base portion forms at least one opening therethrough forinsertion of a material therethrough.
 34. An osteotomy implant accordingto claim 33 wherein the material is at least one selected from the groupconsisting of: allograft bone; autograft bone; demineralized bonesubstitutes; bone graft material; and bone cement.
 35. An osteotomyimplant according to claim 31 wherein the two opposing sides aresubstantially parallel with one another.
 36. An osteotomy implantaccording to claim 31 further comprising a series of projectionsextending from bone interface surfaces of the two opposing side walls,wherein the projections are configured to allow insertion of theopposing side walls into the open wedge osteotomy and prevent migrationof the opposing side walls out of the open wedge osteotomy.
 37. Anosteotomy implant according to claim 31 wherein the two opposing sidewalls define channels therein for delivering selected materialtherethrough.
 38. An osteotomy implant according to claim 37 furthercomprising a delivery device comprising a tube having a length and adiameter, the tube forming a series of openings along the lengththereof, the diameter configured for placement in a main portion of thechannel, and the series of openings configured to correspond with aseries of branch portions of the channel.
 39. An osteotomy implantaccording to claim 31 wherein the two opposing side walls definechannels opening on a bone interface surface thereof so as to allowdelivery of a selected material therethrough.
 40. An osteotomy implantaccording to claim 39 wherein the selected material comprises at leastone chosen from the group consisting of: biocompatible adhesive glue;bone cement; growth factor; and grafting material.
 41. An osteotomyimplant for supporting an open wedge osteotomy, the osteotomy implantcomprising: a base portion having a first height, a first end and asecond end, a width between the first end and the second end, the firstheight configured to substantially close a proximal end of the openwedge osteotomy; two opposing side walls extending from the first endand the second end, respectively, the two opposing side walls having athird end and a fourth end, the third end extending from the baseportion, a second height equal to the first height of the base portionat the third end, each one of the two opposing side walls at the fourthend having a third height, the third height being less than the secondheight so as to allow placement of the fourth end of each one of the twoopposing side walls into a distal portion of the open wedge osteotomy.42. An osteotomy implant according to claim 41 wherein the two opposingwalls are substantially parallel with one another.
 43. An osteotomyimplant according to claim 41 wherein the two opposing side wallsapproach one another in a region between the third end and the fourthend of each one of the opposing side walls, respectively.
 44. Anosteotomy implant according to claim 41 wherein the base portion formsat least one opening therethrough for insertion of a materialtherethrough.
 45. An osteotomy implant according to claim 41 wherein thematerial is at least one selected from the group consisting of allograftbone; autograft bone; demineralized bone substitutes; bone graftmaterial; and bone cement.
 46. An osteotomy implant according to claim41 further comprising a connector extending between the two opposingside walls from a location between the third end and the fourth end ofeach one of the side walls, respectively.
 47. An osteotomy implantaccording to claim 41 wherein the two side walls are selectivelyseparable from one another.
 48. An osteotomy implant according to claim47 wherein the base portion is selectively separable from the two sidewalls.
 49. An osteotomy implant according to claim 48 wherein theselected material comprises at least one chosen from the groupconsisting of biocompatible adhesive glue; bone cement; growth factor;and grafting material.
 50. An osteotomy implant according to claim 47further comprising a series of projections extending from bone interfacesurfaces of the two opposing side walls, wherein the projections areconfigured to allow insertion of the opposing side walls into the openwedge osteotomy and prevent migration of opposing side walls out of theopen wedge osteotomy.
 51. An osteotomy implant according to claim 41wherein the two opposing side walls define channels therein fordelivering selected material therethrough.
 52. An osteotomy implantaccording to claim 51 wherein the selected material comprises at leastone chosen from the group consisting of biocompatible adhesive glue;bone cement; growth factor; and grafting material.
 53. An osteotomyimplant according to claim 51 further comprising a delivery devicecomprising a tube having a length and a diameter, the tube forming aseries of openings along the length thereof, the diameter configured forplacement in a main portion of the channel, and the series of openingsconfigured to correspond with a series of branch portions of thechannel.
 54. An osteotomy implant according to claim 41 wherein the twoopposing side walls define channels on a bone interface surface thereofso as to allow delivery of selected material therein.
 55. An osteotomyimplant according to claim 54 wherein the selected material comprises atleast one chosen from the group consisting of biocompatible adhesiveglue; bone cement; growth factor; and grafting material.
 56. Anosteotomy implant for supporting an open wedge osteotomy, the osteotomywedge implant comprising: two opposing side walls having a first end anda second end in opposition to one another, a pair of frame membersextending between the first end and the second end of each of the twoopposing side walls, an expandable material disposed between the pair offrame members of each of the two opposing side walls, the pair of framemembers in connection with one another at the first end thereof, and thepair of frame members selectively separable from one another to aselected height at the second end thereof; a base member having a givenheight and a given width, wherein the given height is substantiallyequal to the selected height of the pair of frame member of each of thetwo opposing side walls, and wherein the given width is substantiallyequal to a distance between the two opposing side walls when placed inthe open wedge osteotomy; and a set of connectors for connecting thebase member to each of the two opposing side walls.
 57. An osteotomyimplant according to claim 56 wherein base member defines passagewaystherein for disposition of the set of connectors therethrough to connectthe base member to each of the two opposing sides.
 58. An osteotomyimplant according to claim 56 wherein at least one chosen from a groupconsisting of the base portion and the two opposing side walls define anopening therethrough, and the opening is configured for inserting aselected material into the open wedge osteotomy between the two opposingside portions.
 59. An osteotomy implant according to claim 58 whereinthe selected material comprises at least one chosen from the groupconsisting of biocompatible adhesive glue; bone cement; growth factor;and grafting material.
 60. An osteotomy implant according to claim 56further comprising a series of projections extending from bone interfacesurfaces of the two opposing side walls, wherein the projections areconfigured to allow insertion of the opposing side walls into the openwedge osteotomy and prevent migration of opposing side walls out of theopen wedge osteotomy.
 61. An osteotomy implant according to claim 56further comprising an opening wedge plate device for opening each of thetwo opposing side walls at second end, the opening wedge plate havingfour attachment points configured for attachment to each ones of thepair of frame members of each of the two opposing side walls, and twoconnectors for attachment to a jack mechanism, wherein the opening wedgeplate device is configured to support the two opposing side walls as thesecond end of each of the side walls are expanded relative to oneanother.
 62. A multi-part osteotomy implant for supporting an open wedgeosteotomy, the osteotomy implant comprising: a first componentconfigured for disposition in a posterior portion of the open wedgeosteotomy; and a second component configured for disposition in ananterior portion of the open wedge osteotomy; wherein the firstcomponent and the second component form a U-shaped wall when disposed inthe open wedge osteotomy.
 63. A multi-part osteotomy implant accordingto claim 62 wherein the first component and the second component areconfigured for disposition adjacent to one another in the open wedgeosteotomy so as to contact one another.
 64. A multi-part osteotomyimplant according to claim 63 wherein the first component and the secondcomponent are configured for disposition in the open wedge osteotomyunconnected with one another.
 65. A multi-part osteotomy implantaccording to claim 62 wherein the first component and the secondcomponent are configured for disposition in the open wedge osteotomyunconnected with one another.
 66. A multi-part osteotomy implantaccording to claim 62 further comprising a third component configuredfor disposition in a medial portion of the open wedge osteotomy, whereinthe first component, the second component and the third component formthe U-shaped wall when disposed in the open wedge osteotomy.
 67. Amulti-part osteotomy implant according to claim 66 wherein the firstcomponent and the second component are configured for dispositionadjacent to one another in the open wedge osteotomy so as to contact oneanother, and the second component and the third component are configuredfor disposition adjacent to one another in the open wedge osteotomy soas to contact one another.
 68. A multi-part osteotomy implant accordingto claim 67 wherein the first component and the second component areconfigured for disposition in the open wedge osteotomy without being indirect contact with one another.
 69. An osteotomy implant for supportingan open wedge osteotomy, the osteotomy implant comprising: a U-shapedwall configured for disposition in the open wedge osteotomy, an interiorportion formed on a concave side of the wall, and an exterior portionformed on a convex side of the wall; and the U-shaped wall forming anaccess port therethrough from the exterior portion into the interiorportion, wherein the access port allows passage of a material betweenthe exterior portion and the interior portion.
 70. An osteotomy implantaccording to claim 69 wherein the access port is configured in a medialportion of the U-shaped wall when the osteotomy implant is disposed inthe open wedge osteotomy.
 71. An osteotomy implant according to claim 69wherein the access port is configured in a posterior portion of theU-shaped wall when the osteotomy implant is disposed in the open wedgeosteotomy.
 72. An osteotomy implant according to claim 69 wherein theaccess port is configured in a anterior portion of the U-shaped wallwhen the osteotomy implant is disposed in the open wedge osteotomy. 73.An osteotomy implant according to claim 69 wherein the U-shaped wallforms an additional access port therethrough from the exterior portioninto the interior portion.
 74. An osteotomy implant according to claim73 wherein one of the access port and the additional access port areconfigured to allow overflow of the material to exit from the interiorportion as the material is injected through the other one thereof.
 75. Amulti-part osteotomy implant for supporting an open wedge osteotomy, theosteotomy implant comprising: a first component configured fordisposition in a posterior portion of the open wedge osteotomy; and asecond component configured for disposition in an anterior portion ofthe open wedge osteotomy; wherein the first component comprises a firstmaterial, the second component comprises a second material, and thefirst material and the second material are different from one another.76. A multi-part implant according to claim 75 wherein the firstcomponent and the second component are configured for dispositionadjacent to one another in the open wedge osteotomy so as to contact oneanother.
 77. A multi-part implant according to claim 76 wherein thefirst component and the second component form a U-shaped wall whendisposed in the open wedge osteotomy.
 78. A multi-part implant accordingto claim 75 further comprising a third component configured fordisposition in a medical portion of the open wedge assembly, wherein thethird component comprises a third material, and further wherein thefirst material, second material, and third material are each differentfrom one another.
 79. A multi-part implant for supporting an open wedgeosteotomy, the osteotomy comprising: a first component configured fordisposition in a posterior portion of the open wedge osteotomy; a secondcomponent configured for disposition in an anterior portion of the openwedge osteotomy; a third component configured for disposition in amedial portion of the open wedge osteotomy; and wherein the firstcomponent comprises a first material, the second component comprises asecond material, the third material comprises a third material, and oneselected from the group consisting of the first material, the secondmaterial, and the third material is different than another one selectedfrom the group consisting of the first material, the second material,and the third material.
 80. A multi-part implant according to claim 79wherein the third material is different than the first material and thesecond material.
 81. A multi-part implant according to claim 79 whereineach of the first material, the second material and the third materialare different from one another.